Auriculotherapy in the Treatment of Dysmenorrhea

October 19, 2018 updated by: Luciane Cruz Lopes, University of Sorocaba

Effect of Auriculotherapy in the Treatment of Dysmenorrhea: Protocol of a Randomized Controlled Clinical Trial

This study aims to determine if auriculotherapy is effective in the treatment of dysmenorrhoea. This intervention consists of fixation of yellow mustard seeds at specific points of the auricular pavilion (or area), with opaque tape. Half of the participants will have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while the other half will have only the adhesive plasters fixed, without the seeds for stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary dysmenorrhoea is responsible for the most part of dissatisfactions in the female class, in the face of discomforts which are caused monthly. For this, the income index of this woman in the work environment tends to reduce, thus harming the development of every sector to which she responds. The expected effects, after the intervention, will be positive, favoring a considerable improvement of the symptoms reported by the women. We chose auriculotherapy because it is a non-medicated, noninvasive intervention that is inexpensive.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Sorocaba, São Paulo, Brazil, 18023-000
        • Universidade de Sorocaba - Campus Cidade Universitária

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • To be eligible to participate in this study, the individual must meet the following criteria:

    • Free and informed consent form, duly signed and dated
    • Consent to voluntarily participate in all study procedures and availability for the duration of the study
    • Female subjects
    • Age above of 18 years old
    • Enjoy good general health
    • Have active menstrual cycle
    • Complaint about dysmenorrhea

Exclusion Criteria:

  • An individual who meets any of the following criteria will be excluded from participation in this study:

    • Clinical diagnosis of endometriosis
    • Myomas
    • Pelvic inflammatory disease
    • Adenomyosis
    • In the active phase for treatment of cancer (chemotherapy or radiotherapy)
    • Women who are already in menopause
    • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Auriculotherapy with application of mustard seeds fixed with adhesive tape at specific points in the auricle during one session per week lasting 20 minutes for 3 consecutive months.
Device: auriculotherapy
The participants will be submitted to a session per week with duration of 20 minutes, for three consecutive months, to fix the adhesives. The points selected for stimulation, according to Chinese atrial mapping, are: uterus, endocrine, ovary, pituitary, shen men, sympathetic, and liver. Participants will be advised to remain with the stickers fixed to the auricle for six days.
Other Names:
  • acupuncture
PLACEBO_COMPARATOR: Control
Auriculotherapy with tape-only fixation in the auricle, without mustard seeds, following the same stitch protocol used with the intervention group, during a session per week lasting 20 minutes, for three consecutive months.
Device: auriculotherapy
The participants will be submitted to a session per week with duration of 20 minutes, for three consecutive months, to fix the adhesives. The points selected for stimulation, according to Chinese atrial mapping, are: uterus, endocrine, ovary, pituitary, shen men, sympathetic, and liver. Participants will be advised to remain with the stickers fixed to the auricle for six days.
Other Names:
  • acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement on pain perception
Time Frame: 12 weeks
The numerical visual scale of pain 0-10 (0 = no pain, 10 = worst possible pain), applied at the beginning of the intervention period and reapplied to each menstrual period during the 12 weeks of follow-up will be used.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Welfare
Time Frame: 12 weeks
The quality of life questionnaire (Short-Form Health Survey SF36) will be applied at the beginning of the intervention period and reapplied at the end of the 12 weeks of intervention.
12 weeks
Number of participants with adverse events
Time Frame: 12 weeks
Adverse events will be collected spontaneously by the active survey, at all visits of participants.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sorocaba

Investigators

  • Principal Investigator: Luciane Cruz Lopes, Universidade de Sorocaba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2017

Primary Completion (ACTUAL)

August 30, 2018

Study Completion (ACTUAL)

October 15, 2018

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (ACTUAL)

May 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45269015.3.0000.5500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We intend to share the data six months after the conclusion of the study

IPD Sharing Time Frame

Data will be available since the study were published.

IPD Sharing Access Criteria

Data access requests should be made via an application form detailing the specific requirements and the proposed research and publication plan. Any request access will be controlled to types of data analyses, process for requesting data/documents. We will discuss with the team of researcher the "quality of request".

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Dysmenorrhea

Clinical Trials on auriculotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe